BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 9792964 · Received March 5, 2020

    Report

    Report Number
    9616066-2020-00720
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 11, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION IDENTIFIED BOTH SMARTSITE COMPONENTS ON EACH SET TO BE OVAL SHAPED. FUNCTIONAL TESTING CONFIRMED THE CUSTOMER¿S EXPERIENCE AS LEAKAGE WAS OBSERVED FROM THE OVAL SMARTSITES. A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE CAUSE OF THIS ISSUE IS EXPOSURE OF THE SMARTSITE® TO AN EXTERNAL HEAT SOURCE THAT BRINGS THE COMPONENT TEMPERATURE ABOVE 60°C. UNDER EXCESSIVE HEAT CONDITIONS, THE FLA MATERIAL CAN SOFTEN, AND AS THE PISTON PUSHES BACK ON THE INSIDE, IT CAN RESHAPE THE FLA TO CONFORM TO THE ORIGINAL OVAL-SHAPE OF THE PISTON HEAD. A REVIEW OF THE MANUFACTURING PROCESS, BD STORAGE CONDITIONS, AND STERILIZATION PROCESS HAS NOT FOUND A POTENTIAL ROOT CAUSE FOR THIS LEVEL OF EXCESS HEAT.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS SMARTSITE LEAKED.

    Additional Manufacturer Narrative · 1

    30262E-0006/NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 30262E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS SMARTSITE LEAKED FROM THE REPORTED INFORMATION, THERE WAS NO PATIENT OR USER HARM AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254591 SMARTSITE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 30262E-0006 18045019

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)30262E-0006, THERAPY DATE 02/11/2020